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Regulation · Permit

FDA 510(k): NaviCam Xpress Magnetically Maneuvered Capsule Endoscopy (K231960)

FDA cleared the NaviCam Xpress magnetically maneuvered capsule endoscopy system for small bowel examination. Uses external magnetic control for capsule navigation through the GI tract.

Jurisdiction: United States · Effective 2023-08-01

Machine-readable surfaces

Sources (1)

  1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231960

Status history

  • In effect · 2023-08-01 · agent-recon

    Initial ingestion

Common questions

What does FDA 510(k): NaviCam Xpress Magnetically Maneuvered Capsule Endoscopy (K231960) cover?
FDA cleared the NaviCam Xpress magnetically maneuvered capsule endoscopy system for small bowel examination. Uses external magnetic control for capsule navigation through the GI tract.
Where does FDA 510(k): NaviCam Xpress Magnetically Maneuvered Capsule Endoscopy (K231960) apply?
FDA 510(k): NaviCam Xpress Magnetically Maneuvered Capsule Endoscopy (K231960) is recorded as a permitting requirement applying in United States on the DEPLOY registry.
When did FDA 510(k): NaviCam Xpress Magnetically Maneuvered Capsule Endoscopy (K231960) take effect?
FDA 510(k): NaviCam Xpress Magnetically Maneuvered Capsule Endoscopy (K231960) is recorded as effective August 1, 2023 on the DEPLOY registry.
Is FDA 510(k): NaviCam Xpress Magnetically Maneuvered Capsule Endoscopy (K231960) still in effect?
FDA 510(k): NaviCam Xpress Magnetically Maneuvered Capsule Endoscopy (K231960) is currently in effect and applies to covered operators in the named jurisdiction.
What types of robots does FDA 510(k): NaviCam Xpress Magnetically Maneuvered Capsule Endoscopy (K231960) apply to?
FDA 510(k): NaviCam Xpress Magnetically Maneuvered Capsule Endoscopy (K231960) is recorded as applying to surgical on the DEPLOY registry.
Which robot models on the DEPLOY registry fall under FDA 510(k): NaviCam Xpress Magnetically Maneuvered Capsule Endoscopy (K231960)?
8 robot models on the DEPLOY registry match the form-factor scope of FDA 510(k): NaviCam Xpress Magnetically Maneuvered Capsule Endoscopy (K231960): ANOVO, Andromeda Surgical Robot, CORI, Carina and 4 others. Form-factor scope match does not by itself establish compliance status; review the underlying primary sources for each operator.
Methodology: Unreviewed · 1 source (1 primary) · last reviewed 2026-08-09

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-08-09

Architectural position

Cohort: surgical

Sources by quality tier

1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for FDA 510(k): NaviCam Xpress Magnetically Maneuvered Capsule Endoscopy (K231960).

Canonical ID a8359dfa-55b5-49f1-aba4-5ff5d986b89d